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The applicant asserted that the code descriptor for C1739, tissue marker, probe detectable any method (implantable), with delivery system, is overly broad, describes numerous legacy tissue marker systems that the applicant believes are not eligible for device pass-through, and does not appropriately differentiate the SCOUT MD TM Delivery System or other similar systems from the wide range of existing tissue markers currently on the market

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However, human bioavailability data for oral BPC-157 is not established through published pharmacokinetic studies

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